MRI-guided Ultrasound for Tremors Gains FDA Approval July 21, 2016 The device is designed to treat essential tremors. Read More
Poor Supplier Controls Prompt 483 for Fluke Biomedical July 20, 2016 Fluke failed to properly select any of the suppliers for its CLEAR-Pb X-Ray shielding products. Read More
Pharmaceutical Innovations Pleads Guilty to Criminal Charges for Contamination July 20, 2016 Ultrasound gel was contaminated with bacteria. Read More
Morris Innovative Lands Six-Item Form 483 July 20, 2016 Morris garnered the 483 over its handling of out-of-specification products, internal audits and CAPA issues. Read More
Zimmer Garners Warning Letter Over Quality Deficiencies July 20, 2016 The letter revealed numerous serious quality system deficiencies, including CAPA. Read More
FDA Releases Guidance To Back EMC Claims July 20, 2016 The FDA provides a checklist of what manufacturers should include in their submissions. Read More
Study Affirms Safety and Efficacy of Flex Robotic System July 19, 2016 Treatment was successful in 91 percent of transoral procedures. Read More
Roundtable Healthcare Sells Off Beaver-Visitec July 19, 2016 Financial terms were not disclosed. Read More
MHRA Releases Guidance on Remanufacturing Single-Use Devices July 19, 2016 The remanufacturer must ensure that the intended use of the device is the same as the original product. Read More
Guidance Maps Out Codevelopment Pathways for Companion Diagnostics, Drugs July 19, 2016 The guidance describes general principles to guide codevelopment. Read More
Medtronic Gains CE Mark Approval for Guardian Connect July 19, 2016 The system is scheduled to be launched on a “country-by-country basis.” Read More
Theranos Hit With CMS Sanctions; Bans CEO From Lab for Two Years July 18, 2016 The actions follow a litany of quality control failures for the blood testing company. Read More